NCT01823367

Brief Summary

This study is a randomized intervention that will test two different approaches reflecting diverse levels of both intensity and cost, to achieving risk reduction of T2D. This will help address a critical question in the translation of primary prevention research into the public health: how much intensity (and thus cost) is required to achieve an effective outcome? In addition, the proposed study will address a critical need in diabetes prevention that has not received sufficient scholarly attention: the prevention of T2D in children. No studies of diabetes prevention similar in scope to the DPP have been performed in school-aged children; however, reducing childhood obesity is widely accepted as the primary pathway to decreasing the growing prevalence of T2D in the pediatric population.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
335

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2012

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 27, 2013

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 4, 2013

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 27, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 27, 2016

Completed
Last Updated

August 25, 2017

Status Verified

August 1, 2017

Enrollment Period

3.4 years

First QC Date

March 27, 2013

Last Update Submit

August 24, 2017

Conditions

Gestational Diabetes MellitusPre-diabetes

Keywords

type 2 diabetes mellitus preventiongestational diabetes mellituspre-diabeteslifestyle interventionspediatric primary prevention of type 2 diabetes

Outcome Measures

Primary Outcomes (1)

  • Changes in weight

    Weight taken during data collection visits

    3, 6, and 12 months after the beginning of the assigned intervention program

Secondary Outcomes (1)

  • Changes in diet

    3, 6, and 12 months after the beginning of the assigned intervention program

Study Arms (2)

Lifestyle counseling mom only

EXPERIMENTAL

This intervention, delivered to groups of mothers only, builds upon the evidence-based curriculum used in the Diabetes Prevention Program (DPP) and incorporates into the curriculum detailed education regarding ways to help their children adopt healthier lifestyle behaviors.

Behavioral: Diabetes Prevention Program (DPP)

Lifestyle counseling mom and child

EXPERIMENTAL

The second intervention is delivered to both mothers and children in separate groups using the same parent Diabetes Prevention Program (DPP) curriculum, but adds a group program for children that directly teach these children strategies for eating better and increasing physical activity.

Behavioral: Diabetes Prevention Program (DPP)

Interventions

Diabetes Prevention Program (DPP)BEHAVIORAL

Diabetes Prevention Program (DPP): This is an evidence-based curriculum that has shown that it is possible to prevent or delay Type 2 Diabetes (T2D) in individuals if they keep a healthy weight, eat a nutritious diet, and stay physically active.

Lifestyle counseling mom and childLifestyle counseling mom only

Eligibility Criteria

Age8 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Adult females, age 18 or greater
  • Body-mass index of ≥ 25 kg/m2
  • Is a biological mother to a child between 8 and 15 years of age (child must live with biological mom)
  • Is a biological mother with past diagnosis or history of gestational diabetes, prediabetes or gave birth to a child who weighed 9 pounds or greater at delivery

You may not qualify if:

  • Biological mother or biological child with diagnosis of Type 1 or 2 Diabetes Mellitus
  • Biological mother or biological child with current A1c \> 6.5%
  • Biological mother or biological child current casual capillary blood glucose \> 220mg/dl
  • Biological mother or biological child with uncontrolled hypertension (Systolic Blood Pressure (SBP) \>180 mmHg or Diastolic Blood Pressure (DBP) \>105 mmHg)
  • Biological mother or biological child with heart attack, stroke, or transient ischemic attack in the past 6 months
  • Biological mother or biological child with chest pain, dizziness, or fainting with physical exertion
  • Biological mother or biological child with Chronic Obstructive Pulmonary Disease (COPD) or asthma requiring home oxygen
  • Biological mother or biological child with cancer treatment in the last 5 years
  • Biological mother or biological child with any other known condition that could limit ability to become physically active or limit life span to \<5 years
  • Biological mother or biological child with history of anti-diabetic medication use (oral agents or insulin) except during past gestational diabetes
  • Biological mother or biological child with self-report of any other condition associated with disordered glucose metabolism (including but not limited to):pregnancy; Cushing's syndrome; acromegaly; pheochromocytoma; chronic pancreatitis
  • Biological mother or biological child with conditions or behaviors likely to affect the conduct of the study (including but not limited to): any reported developmental problems, unable or unwilling to provide informed consent/assent, unable or unwilling to communicate with study staff or engage in learning activities

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Indiana University School of Medicine

Indianapolis, Indiana, 46202, United States

Location

Related Publications (2)

  • Palmer KNB, Garr Barry VE, Marrero DG, McKinney BM, Graves AN, Winters CK, Hannon TS. Intervention Delivery Matters: What Mothers at High Risk for Type 2 Diabetes Want in a Diabetes Prevention Program-Results from a Comparative Effectiveness Trial. Diabetes Ther. 2020 Oct;11(10):2411-2418. doi: 10.1007/s13300-020-00891-1. Epub 2020 Aug 8.

    PMID: 32770443DERIVED

  • Hannon TS, Carroll AE, Palmer KN, Saha C, Childers WK, Marrero DG. Rationale and design of a comparative effectiveness trial to prevent type 2 diabetes in mothers and children: the ENCOURAGE healthy families study. Contemp Clin Trials. 2015 Jan;40:105-11. doi: 10.1016/j.cct.2014.11.016. Epub 2014 Nov 29.

    PMID: 25457793DERIVED

MeSH Terms

Conditions

Diabetes, GestationalGlucose Intolerance

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesHyperglycemia

Study Officials

  • David G Marrero, PhD.

    Inidana University School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
J.O Ritchey Professor of Medicine. Director, Diabetes Translational Research Center

Study Record Dates

First Submitted

March 27, 2013

First Posted

April 4, 2013

Study Start

December 1, 2012

Primary Completion

April 27, 2016

Study Completion

April 27, 2016

Last Updated

August 25, 2017

Record last verified: 2017-08

Locations

US(1)